S2

Dosage form: solution
Ingredients: RACEPINEPHRINE HYDROCHLORIDE 11.25mg in 0.5mL
Labeler: Nephron Pharmaceuticals Corporation
NDC Code: 0487-5901

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Racepinephrine Inhalation Solution, USP 2.25%

Drug Facts

Active ingredient (in each 0.5 ml)

Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

Purpose

Bronchodilator

Uses

For temporary relief of mild symptoms of intermittent asthma:

  • Wheezing
  • Tightness of chest
  • Shortness of breath

Warnings

Asthma alert

Because asthma may be life threatening, see a doctor if you:

  • Are not better in 20 minutes
  • Get worse
  • Need more than 12 inhalations in 24 hours
  • Use more than 9 inhalations in 24 hours for 3 or more days a week
  • Have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

Do not use:

  • Unless a doctor said you have asthma
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
  • If product is brown in color or cloudy

Ask a doctor before use if you have:

  • Ever been hospitalized for asthma
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Seizures
  • Narrow angle glaucoma
  • A psychiatric or emotional condition
  • Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

  • Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
  • Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

Stop use and ask a doctor if:

  • Your asthma is getting worse (See Asthma alert)
  • You have difficulty sleeping
  • You have a rapid heartbeat
  • You have tremors, nervousness, or seizure

When using this product:

Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

  • Your risk of heart attack or stroke increases if you:
    • Have a history of high blood pressure or heart disease
    • Take this product more frequently or take more than the recommended dose.
    • Avoid foods or beverages that contain caffeine
    • Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.

  • If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Do not use more than directed
  • The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
  • For use in a nebulizer:
    Add 0.5 ml (contents of one vial) of solution to nebulizer.
  • Adults and children 4 years of age and over:
    1 to 3 inhalations not more often than every 3 hours. Start with one inhalation, then wait at least 1 minute. If symptoms do not improve, use once more. Do not exceed more than 3 inhalations over a 3 hour period.
    Do not use more than 12 inhalations in 24 hours.
    The use of this product by children should be supervised by an adult.
  • Children under 4 years of age: ask a doctor.

Other Information
  • Protect from light. Avoid excessive heat. Protect from freezing.
  • Store between 2°C and 25°C (36°F and 77°F).
  • How Supplied: S2® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.
    NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.
    NDC 0487-5901-10 10 vials, each vial in an individual foil pouch.
    NDC 0487-5901-02 30 vials, each vial in an individual foil pouch, robot ready.

Inactive Ingredients

Ascorbic acid, citric acid, edetate disodium, water for injection.

Questions?

1-800-443-4313

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Pouch Carton

S2®

NDC 0487-5901-99

Racepinephrine
Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

SULFITE-FREE
PRESERVATIVE-FREE

Manufactured By:

nephron
pharmaceuticals
corporation

Orlando, FL 32811

MADE
IN THE
USA

30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch.

S2 
racepinephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0487-5901
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE11.25 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:0487-5901-9930 POUCH in 1 CARTON
11 VIAL, SINGLE-USE in 1 POUCH
10.5 mL in 1 VIAL, SINGLE-USE
2NDC:0487-5901-0230 BAG in 1 BOX
21 POUCH in 1 BAG
21 VIAL, SINGLE-USE in 1 POUCH
20.5 mL in 1 VIAL, SINGLE-USE
3NDC:0487-5901-1010 POUCH in 1 CARTON
31 VIAL, SINGLE-USE in 1 POUCH
30.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2000
Labeler - Nephron Pharmaceuticals Corporation (783905201)
Registrant - Nephron Pharmaceuticals Corporation (783905201)
Establishment
NameAddressID/FEIOperations
Nephron Pharmaceuticals Corporation783905201MANUFACTURE(0487-5901), ANALYSIS(0487-5901), PACK(0487-5901)

Revised: 09/2014
 
Nephron Pharmaceuticals Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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